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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-003186-18
    Sponsor's Protocol Code Number:LOWOL-19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003186-18
    A.3Full title of the trial
    EFICACY AND TOLERABILITY OF TWO REDUCED VOLUME PRODUCTS FOR COLORRECTAL CANCER SCREENING COLONOSCOPY: A COMPARATIVE, PARALLEL RANDOMIZED CLINICAL TRIAL. LOWOL STUDY.
    EFICACIA Y TOLERABILIDAD DE DOS PRODUCTOS DE VOLUMEN REDUCIDO PARA LA COLONOSCOPIA DE CRIBADO DE CÁNCER COLORRECTAL: ENSAYO COMPARATIVO PARALELO ALEATORIZADO. LOWOL Study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFICACY AND TOLERABILITY OF TWO REDUCED VOLUME PRODUCTS FOR COLORRECTAL CANCER SCREENING COLONOSCOPY: A COMPARATIVE, PARALLEL RANDOMIZED CLINICAL TRIAL. LOWOL STUDY.
    EFICACIA Y TOLERABILIDAD DE DOS PRODUCTOS DE VOLUMEN REDUCIDO PARA LA COLONOSCOPIA DE CRIBADO DE CÁNCER COLORRECTAL: ENSAYO COMPARATIVO PARALELO ALEATORIZADO. LOWOL Study.
    A.3.2Name or abbreviated title of the trial where available
    LOWOL-19
    LOWOL-19
    A.4.1Sponsor's protocol code numberLOWOL-19
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundació Clínic per a la Recerca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC
    B.5.2Functional name of contact pointJoan Albert Arnaiz
    B.5.3 Address:
    B.5.3.1Street AddressC. Villarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932279838
    B.5.5Fax number34932279877
    B.5.6E-mailjaarnaiz@clinic.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pleinvue®
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmacrogol
    D.3.9.1CAS number 25322-68-3
    D.3.9.3Other descriptive nameMACROGOL 3350
    D.3.9.4EV Substance CodeSUB20628
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Citrafleet
    D.2.1.1.2Name of the Marketing Authorisation holderCasen Recordati, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcitric acid
    D.3.9.1CAS number 77-92-9
    D.3.9.3Other descriptive nameCITRIC ACID ANHYDROUS
    D.3.9.4EV Substance CodeSUB29050
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.97
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    compare the adenoma detection rate between the two products
    Comparar la tasa de detección de adenomas entre amabos productos
    E.1.1.1Medical condition in easily understood language
    how many benign tumors can be detected with each product
    cuántos tumores benignos pueden detectarse con cada producto
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the clinical efficacy between two products in individuals who will undergo a colonoscopy in a CCR screening program.
    Comparar la eficacia clínica entre dos productos en individuos que se someterán a una colonoscopia en un programa de cribado de CCR.
    E.2.2Secondary objectives of the trial
    - Compare the Injury Detection Rate (TDL) between both medications.
    - Compare the quality of colonic cleaning (Boston classification)
    - Compare tolerability and satisfaction
    - Compare the rates of adverse effects
    - Evaluate the factors associated with the quality of the preparation between both medications
    - Evaluate the correlation between colonic cleaning quality and clinical efficacy in global and in each product
    - Evaluate the factors associated with the tolerability of both medications
    - Evaluate the factors associated with the satisfaction of both medications
    - Evaluate the factors associated with the occurrence of adverse effects in both medications.
    - Compare the pregnancy survival curve between the Study and the Placebo Group.
    - Comparar la Tasa de Detección de Lesiones (TDL) entre ambos medicamentos.
    - Comparar la calidad de la limpieza colónica (clasificación de Boston)
    - Comparar la tolerabilidad y satisfacción
    - Comparar la tasas de efectos adversos
    - Evaluar los factores asociados a la calidad de la preparación entre ambos medicamentos
    - Evaluar la correlación entre calidad de limpieza colónica y eficacia clínica en global y en cada producto
    - Evaluar los factores asociados a la tolerabilidad de ambos medicamentos
    - Evaluar los factores asociados a la satisfacción de ambos medicamentos
    - Evaluar los factores asociados a la aparición de efectos adversos en ambos medicamentos.
    - Comparar la curva de supervivencia de la gestación entre el Estudio y el Grupo Placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women 50 to 69 years old
    2) Have participated in the Program for early detection of colon and rectal cancer
    3) Positive result in the fecal occult blood test (≥20 μg Hb / g feces)
    4) Have scheduled screening colonoscopy at the Hospital Clínic de Barcelona
    5) Have signed the informed consent.
    1) Hombres y mujeres de 50 a 69 años
    2) Haber participado en el Programa de detección precoz de cáncer de colon y recto
    3) Resultado positivo en el test de sangre oculta en heces (≥20 μg Hb/g heces)
    4) Tener programada colonoscopia de cribado en el Hospital Clínic de Barcelona
    5) Haber firmado el consentimiento informado.
    E.4Principal exclusion criteria
    1) People affected by known severe renal impairment (grade IV or V) and congestive heart failure (class III and IV according to the New York Heart Association Scale)
    2) People who have performed a colonoscopy during the last year
    3) People who meet the Rome IV Criteria for the diagnosis of functional constipation
    4) Persons with mental disabilities or severe mental disorders (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders)
    5) People who do not understand Catalan or oral and written Spanish
    6) People with partial or total colon resection
    7) People with a personal history of CRC or tributary colorectal pathology of a specific follow-up (ulcerative colitis, Crohn's disease or colorectal adenomas)
    8) People with terminal illness or serious illness / disability that contraindicates the subsequent study of the colon
    9) Persons who do not sign the informed consent
    1) Personas afectadas de insuficiencia renal grave (grado IV o V) conocida e insuficiencia cardíaca congestiva (clase III y IV según la Escala de la New York Heart Association)
    2) Personas que hayan realizado una colonoscopia durante el último año
    3) Personas que cumplan los Criterios de Roma IV para el diagnóstico de estreñimiento funcional
    4) Personas con discapacidad mental o trastorno mental grave (esquizofrenia y otros trastornos psicóticos, trastornos depresivos mayores graves recurrentes, trastorno obsesivo-compulsivo grave, trastornos de la personalidad severos y trastornos bipolares)
    5) Personas que no comprendan el catalán o el español oral y escrito
    6) Personas con resección parcial o total del colon
    7) Personas con antecedentes personales de CCR o patología colorrectal tributaria de un seguimiento específico (colitis ulcerosa, enfermedad de Crohn o adenomas colorrectales)
    8) Personas con enfermedad terminal o enfermedad/invalidez grave que contraindique el estudio posterior del colon
    9) Personas que no firmen el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Adverse reaction to the product
    reacción adversa al producto
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1
    Visita 1
    E.5.2Secondary end point(s)
    None
    Ninguna
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    Ninguno
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LV/LP
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 364
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state828
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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